Compass Group

The FDA has granted Compass Pathways a rolling review for the marketing application of COMP360, a synthetic psilocybin treatment for treatment‑resistant depression, and has included the drug in the Commissioner’s National Priority Voucher program. The program enables intensified communication with the agency and shortens review time by one to two months while keeping safety and efficacy requirements unchanged. Compass Pathways cites positive phase‑3 data with over 1,000 participants, significant results, rapid onset within one day and a sustained effect in responders of up to six months; the stock rose thereafter. » Altro su de.investing.com

The FDA selected Compass Pathways' synthetic psilocybin formulation COMP360 for the Commissioner’s National Priority Review Voucher program for treatment-resistant depression and approved continued submission of a New Drug Application based on Phase 3 data. Data from two Phase 3 studies with more than 1,000 participants showed statistically significant efficacy and a predominantly well-tolerated safety profile. The voucher shortens the review time after NDA submission by one to two months without changing the FDA's safety and efficacy standards. Compass is preparing commercially for a possible market launch if approval is granted. » Altro su de.investing.com

Compass Pathways presented positive study data on COMP360 for treatment-resistant depression at the Stifel Forum and plans a staggered NDA submission with completion by the end of 2026. The company secured $150 million in new financing and exercised warrants worth $200 million, extending its liquidity runway through 2028. Key hurdles remain regulatory steps—particularly DEA rescheduling and reimbursement; a PTSD study start and an expected PDUFA date from late 2026 to early 2027 were also announced. » Altro su de.investing.com